Advanced or Recurrent Endometrial Cancer Clinical Trial
Official title:
A Phase II Trial of Docetaxel / Cisplatin in Patients With Recurrent or Stage IVb Endometrial Cancer
The purpose of this study is to treat advanced or recurrent endometrial cancer, paclitaxel-containing regimen is the preferred chemotherapeutic regimen which is selected by most physicians. Docetaxel may have similar efficacy and more favorable treatment related toxicity profile as tested in epithelial ovarian cancer trials. Therefore, the investigators aimed to evaluate the efficacy and safety of docetaxel plus cisplatin in patients with advanced or recurrent endometrial cancer.
| Status | Recruiting |
| Enrollment | 59 |
| Est. completion date | December 2017 |
| Est. primary completion date | December 2017 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 20 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - Histologically confirmed chemotherapy naïve endometrial cancer - One of following histology Endometrioid, UPSC, CCCa, squamous, adenosquamous, mixed - FIGO stage IVb or recurrent endometrial cancer (incurable by surgery and/or RT) - At least one measurable lesion by RECIST on CT - ECOG PS: 0-2 - Age: 20-75 - Adequate organ function BM: ANC=1,000/mm3, Plt=100X103/mm3 Kidney: Creatinine<1.25 × UNL??, GFR = 60 Liver: AST, ALT< 3×UNL, T- bil<1.5 mg/ mm3 - Informed Consent - Contraception during study period Exclusion Criteria: - Previous chemotherapy - RT, hormone therapy, or immunotherapy within 1 month - Other malignant disease - Uncontrolled medical disease - Infection requiring antibiotics - Symptomatic CHF, RF, Angina, Arrhythmia, etc. - Neurosis or psychosis - Pregnancy, breast-feeding - Etc. |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Asan Medical Center | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Asan Medical Center | Boryung Pharmaceutical Co., Ltd |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Response rate | 3 months after completion of study treatment | ||
| Secondary | Progression-free survival | 2 years after completion of study treatment | ||
| Secondary | Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Before each chemotherapy, an expected average of 3 weeks | ||
| Secondary | Quality of life | 3 months after completion of study treatment |